Safety Evaluation of Adverse Reactions in Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— SAFEGUARD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092597
• Other study ID #: HEALTH-282521-CUNI
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2014
• Last updated: February 6, 2018
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of incretin-based antidiabetic therapies (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system and to detail the mechanisms underlying their action in these systems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

• Metformin monotherapy - stable dose during last 3 months

• HbA1C 48-75 mmol/mol (IFCC)

• BMI 25-40 kg/m2

• Age 35-70 years (women postmenopausal)

• Use of ACE inhibitors or ATII receptor blockers for at least 3 months before enrollment

Exclusion Criteria:

• eGFR<30 ml/min/1.73m2 (MDRD)

• Treatment with incretin mimetics during 3 months before enrollment

• Chronic insulin therapy

• Chronic use of loop diuretics, glucocorticoids, NSAID, immune suppressants, antimicrobial agents, chemotherapeutics, bile acid sequestrants (colestyramin, colesevelam)

• History of pancreatic disease or impaired pancreatic function (defined as the need to use pancreatic enzymes)

• Active liver disease or a 3-fold elevation of liver transaminases (ALT, AST)

• Active malignancy

• History of severe cardiovascular disease including acute coronary syndrome, stroke or transient ischemic neurologic disorder during previous 6 months, atrial fibrillation or other arrhythmia requiring chronic antiarrhythmic medication, chronic heart failure (New York Heart Association grade III/IV)

• History of alcohol abuse, defined as >4 units of alcohol/day (32 g or 40 ml of 100% alcohol)

• History of allergy for GLP-1 receptor agonists or DPP-4 inhibitors

• Any disease that could interfere with study procedures (e.g. decreased mobility, mental incapacity)

• Inability to give informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Exenatide

• Linagliptin

• Gliclazide

Locations

Country	Name	City	State
Czechia	General University Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate		90 days after treatment initiation
Primary	Gastric evacuation velocity		90 days after treatment initiation
Primary	Blood pressure		90 days after treatment initiation
Primary	Left ventricular ejection fraction		90 days after treatment initiation
Primary	Intimomedial thickness		90 days after treatment initiation
Primary	Pulse wave velocity		90 days after treatment initiation
Primary	Glomerular filtration rate		90 days after treatment initiation
Primary	Tubular function		90 days after treatment initiation
Primary	KIM-1	Marker of renal damage	90 days after treatment initiation
Primary	Exocrine pancreas function		90 days after treatment initiation